Clinical trials: Infant Outcomes
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping…
- Trial name
- CORDMILK (NCT03657394)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Transfusion
Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions
Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators.
- Trial name
- cell salvage (NCT01211366)
- Testing
- Cell Saver RBCs, Conventional volume infusion
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- University of Rochester
Premature Infants, Bronchopulmonary Dysplasia
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term…
- Conditions
- Premature Infants, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Neurodevelopmental Outcomes
- Trial name
- OptiSTART (NCT05849077)
- Testing
- Sat75, Sat50
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- University of Texas Southwestern Medical Center
Respiratory Distress Syndrome in Premature Infant
Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress…
- Trial name
- NCT03620448
- Testing
- bCPAP Arm, Oxygen Arm
- Volunteers
- 48 people
- Sponsor
- Kilimanjaro Christian Medical Centre, Tanzania
Migraine
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
- Trial name
- MONITOR (NCT05046613)
- Testing
- Rimegepant, Not taking Rimegepant
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Pfizer
Maternal Outcomes, Infant Outcomes
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital…
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Trial name
- NCT06369272
- Where
- United States
- Volunteers
- 1,192 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Weight Gain, Anemia, Iron Deficiency
Egg Intervention During Pregnancy in Indonesia
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers.
- Conditions
- Weight Gain, Anemia, Iron Deficiency, Birth Weight, Birth Length
- Trial name
- PRECODE (NCT04694235)
- Testing
- Egg intervention
- Where
- Indonesia
- Volunteers
- 702 people, healthy volunteers welcome
- Sponsor
- SEAMEO Regional Centre for Food and Nutrition
Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy.
- Trial name
- NCT06299748
- Testing
- Efgartigimod
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 279 people
- Sponsor
- argenx
Preterm
Long Term Health Cohort of Premature Infants
Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and…
- Trial name
- NCT05017389
- Testing
- Griffiths development scales
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Shanghai Children's Medical Center
Cow Milk Protein Allergy
Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
- Trial name
- NCT07711938
- Testing
- New generation eHF, Commercial eHF
- Volunteers
- 410 people
- Sponsor
- Société des Produits Nestlé (SPN)
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Kangaroo-Mother Care, Preterm Infants
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams…
- Trial name
- NCT06707376
- Testing
- Early Kangaroo Mother Care
- Where
- Egypt
- Volunteers
- 240 people
- Sponsor
- Jouf University
Premature Infants
The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes
The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.
- Trial name
- NCT05807191
- Testing
- Kangaroo care based on kangaroo care guide
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Risky Baby
Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants
This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.
- Trial name
- NCT07534748
- Testing
- Family Care Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Inonu University
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Congenital Heart Disease
Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood…
- Trial name
- NCT01134302
- Testing
- Norwood management strategy, Hybrid Strategy
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- The Hospital for Sick Children
Premature Birth of Newborn
Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care.
- Trial name
- mFI-Care (NCT03418870)
- Testing
- Family Integrated Care
- Where
- 6 sites in United States
- Volunteers
- 347 people
- Sponsor
- University of California, San Francisco
Premature Infants
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with…
- Trial name
- NCT03914690
- Testing
- Erythropoietin, Normal saline
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Zhengzhou University
Bronchopulmonary Dysplasia
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia
- Trial name
- NCT04062136
- Testing
- stem cell transplantation
- Where
- Vietnam
- Volunteers
- 10 people
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
Infant, Intubation Complication
Optimizing Tracheal Intubation Outcomes and Neonatal Safety
The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the…
- Trial name
- OPTION SAFE (NCT05838690)
- Testing
- Personalized Intubation Safety (PINS) Bundle
- Where
- 8 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Children's Hospital of Philadelphia